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Wednesday, 02/09/2022 2:15:24 PM

Wednesday, February 09, 2022 2:15:24 PM

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Gamida Cell Shares Surge On Rolling Omidubicel Marketing Application In US

https://www.benzinga.com/general/biotech/22/02/25511786/gamida-cell-shares-surge-on-rolling-omidubicel-marketing-application-in-us?utm_campaign=partner_feed&utm_source=TechInvestorNews&utm_medium=partner_feed&utm_content=site

by Vandana Singh

February 9, 2022 12:54 PM | 1 min read

GMDA has initiated the Biologics License Application (BLA) rolling submission process with the FDA for omidubicel, in patients with blood cancers needing stem cell transplant.

The company remains on track to complete the BLA submission in Q2 of 2022.
Omidubicel has the potential to be the first FDA-approved advanced cell therapy product for allogeneic stem cell transplant.